French Translation and Validation of the Brief Index of Sexual Functioning for Men

Not yet recruiting

• Conditions: Sexual Dysfunction Male
• Interventions: Other: Questionnaire

• Registration Number: NCT05960682
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Sexual dysfunction consists of a disorder of the sexual response, either in terms of desire, or in terms of vasocongestion, or in terms of orgasmic response, or in more than one phase of this response :

Sexual dysfunctions are today described by the Diagnostic and Statistical Manual (DSM) V as:

* Disorders of sexual desire or decreased libido

* Sexual arousal disorder

* Delayed or absent orgasmic disorder

* Sexual disorder with pain Moreover, sexual dysfunctions are not without consequences on the life of a couple. The origins of these dysfunctions are multiple, but the result is most of the time the same: fear of failure, feeling of incompetence, anxiety, frustration or misunderstanding.

To date, the scientific community benefits from a few self-administered questionnaires to measure the impact of certain dysfunctions. None takes into account all the dimensions of male sexuality. In Italy, the Brief Index of Sexual Functioning for Men is used. This questionnaire contains 22 items, grouped into 7 areas exploring all of male sexuality: desire, arousal, frequency of activity, receptivity, pleasure/orgasm, relationship satisfaction, problem affecting sexuality. This questionnaire is not currently validated in French, whereas the Brief Index of Sexual Functioning for Women is validated.

Detailed Description

In this context, the Andrology Committee of the French Association of Urology wishes to create a pilot study with French patients presenting sexual dysfunctions with the aim of validating the questionnaire in French. Patient responses to each item will:

* to determine if the formulation of the items is understandable by all, or if this is not the case

* to identify the difficulties it can cause, and their causes. Patients treated for sexual dysfunction will be informed of the possibility of answering a questionnaire and that their data will be recorded for the purpose of studying practices and analyzing the results in an anonymous setting, and confidential via the delivery of the information leaflet dedicated to the study. They will have the opportunity to signify their refusal to participate without risk of modification of the coverage.

Study Timeline

• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-17
• Study First Posted: 2023-07-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Start: 2024-12-31
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Adult patient with sexual dysfunction

Exclusion Criteria

• Patient refusing to participate
• Patient with difficulties in understanding the French language.
• Protected persons referred to in Articles L.1121-6 to L.1121-8 of the Public Health Code

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Questionnaire	Questionnaire	Men will complete the French version of the Brief Index of Sexual Functioning for Men paper questionnaire.

Primary Outcome Measures

Name	Time	Method
Response rate to the paper questionnaire	Day 1	Answer two sub-questions a) and b) after each item of the scale. These answers will allow to determine if the formulation of the items is understandable by all, or if this is not the case, to identify the difficulties it can cause, and their causes.